Efficacy and safety of acupuncture combined with pelvic floor muscle training in the treatment of stress urinary incontinence in women: A systematic review meta-analysis.

In summary, the current evidence suggests that compared with PFMT alone, acupuncture combined with PFMT has more advantages in the treatment of female SUI, reducing the impact of urinary incontinence on life and improving the quality of life of patients. However, high-quality, large-sample multicenter RCTs are needed for verification.

Stress urinary incontinence (SUI) refers to the involuntary leakage of urine from the external urethral opening when abdominal pressure increases, such as jumping, sneezing, coughing and laughing, and is one of the common types of female urinary incontinence in clinical practice. [ 1 ] Due to the differences in ethnic differences, diagnostic criteria and investigation groups, the prevalence of SUI reported by various studies was inconsistent, ranging from 10% to 40%. [ 2 ] According to a large national epidemiological survey conducted in China, the prevalence rate of SUI among adult women was 18.9%, and the peak age of SUI was around 50 years old [ 3 ] The occurrence of SUI is closely related to pregnancy, childbirth, menopause, obesity and other factors. [ 4 – 7 ] To some extent, SUI has become a social disease, seriously affecting women’s physical and mental health and quality of life, and bringing heavy economic burden to individuals, families, and society. At present, the main clinical treatment methods for SUI include surgical treatment and nonsurgical treatment. Nonsurgical treatment includes drug therapy (α-adrenoceptor agonist, estrogen, etc), biofeedback stimulation, pelvic floor muscle training (PFMT), and traditional Chinese medicine treatment. [ 8 ] In recent years, traditional Chinese medicine, especially acupuncture and moxibustion therapy, has shown obvious characteristic advantages in the treatment of SUI. [ 9 , 10 ] Acupuncture, as a traditional Chinese medicine treatment, has been included in the Representative List of the Intangible Cultural Heritage of Humanity by the United Nations Educational, Scientific and Cultural Organization. [ 11 , 12 ] It is widely used in the treatment of various diseases in clinical practice, and is considered to be a safe and effective therapy. Previous studies have confirmed the advantages of acupuncture in the treatment of gynecological diseases (post-cesarean section pain, polycystic ovary syndrome, endometriosis, etc), [ 13 – 16 ] and acupuncture is recommended in 87.8% of obstetrics and gynecology and women’s guidelines. [ 17 ] Acupuncture has a definite effect on SUI. [ 9 , 18 ] In recent years, acupuncture and moxibustion combined with PFMT has made some progress in improving the clinical symptoms of SUI patients, and a number of studies have confirmed that acupuncture and moxibustion can increase the total effective rate of patients with SUI, reduce the urine leakage (UL) on a 1-hour pad test, relieve the influence of SUI on patients’ life, so as to improve their quality of life. [ 9 , 10 ] However, there is still a lack of high-quality systematic reviews in the domestic and overseas. The published reviews had some shortcomings (such as insufficient number of included literatures, too long publication time of literatures, incomplete search database, etc), and several recently published high-quality randomized controlled trials (RCTs) were not included. In addition, the literature involved in the existing reviews usually included 2 interventions, acupuncture or moxibustion, and there is a lack of meta-analysis on acupuncture combined with PFMT for SUI. Therefore, in order to synthesize more evidence to confirm the role of acupuncture combined with PFMT in the treatment of this disease. We included articles published in the last 5 years in a more comprehensive meta-analysis assessing the efficacy and safety of this combination treatment.

Data curation: Shuangquan Zhu. Funding acquisition: Liangyi Xiao. Investigation: Yanli Peng. Methodology: Yanli Peng. Supervision: Dan Zhou. Writing – original draft: Liangyi Xiao. Writing – review & editing: Liangyi Xiao, Shuangquan Zhu, Dan Zhou.

The protocol of this review has been registered in the International Prospective Register of Systematic Reviews, and the approval number for registration is CRD42024499500. It was reported following the statement guidelines of preferred reporting items for systematic reviews and meta-analyses protocols. [ 19 ] The literature search was conducted in database, including 4 English databases (PubMed, EMBASE, Web of Science, and Cochrane Library) and 4 Chinese databases (the China National Knowledge Infrastructure, Wanfang DATA, the Chongqing VIP Database, and China Biomedical Database), were manually searched for literature published from dates of the inception of the databases to December 23rd, 2023 (Beijing time). In order to comprehensively search and obtain relevant literature, a manual search was carried out using the following search terms and their variants: SUI, PFMT and acupuncture. Detailed retrieval strategies are provided in Content S1, Supplemental Digital Content, https://links.lww.com/MD/Q733 . Participants: Patients with a clinical diagnosis of SUI were considered regardless of nationality, race, gender, occupation, or educational background. All patients should be diagnosed with SUI according to at least one of the current or past SUI definitions or guidelines, such as: Gynecological Pelvic Floor Group, Society of Obstetrics and Gynecology, Chinese Medical Association. Guidelines for the diagnosis and management of SUI in women (2017). [ 20 ] Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. [ 21 ] Incontinence: 5th International Consultation on Incontinence. [ 22 ] Intervention: The experimental group was given acupuncture combined with PFMT. Comparision: The control group was only given PFMT. Outcomes: One of the following outcomes was reported: Primary outcome including total effective rate and UL on a 1-hour pad test; secondary outcome including International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores, Quality of life questionnaire (I-QOL) scores. Study design: RCTs involving patients diagnosed with SUI. Reviews, case reports, research protocols, or conference papers. Animal and in vitro studies. Duplication and lack of access to full texts. Literature with outcome indicators or data errors could not be extracted. Two reviewers Liangyi Xiao and Shuangquan Zhu independently screened the literature according to the above criteria, and the different opinions encountered during the research screening process were resolved through discussion or by the third reviewer Dan Zhou. Two reviewers (Liangyi Xiao and Shuangquan Zhu) independently extracted data from the final included literature, including first author, publication year, country, intervention and control measures, duration of treatment, basic information about study subjects, outcome measures, etc. Included studies will be evaluated by 2 independent reviewers (Liangyi Xiao and Shuangquan Zhu) using the Cochrane Bias Risk Assessment Tool (RoB2.0) [31462531] on 5 aspects of included randomized controlled studies: Bias arising from randomization, bias from deviations from established interventions, bias from missing outcome data, bias from outcome measurement, bias from selective reporting of results. For each study, an independent quality assessment was conducted by 2 researchers, who rated the 5 aspects as “low risk,” “high risk,” and “possibly risky.” The diverging literature was evaluated through discussion or the suggestion of a third investigator, and the evaluation results were shown in the bias risk map. The main outcome indicator are total effective rate, UL on a 1-hour pad test. The secondary outcome including ICIQ-SF score and I-QOL score. We performed a meta-analysis using stata 15.1. For continuous data, when using the same scale, weighted mean differences (WMD) were calculated and 95% confidence intervals (CI) were reported. For binary categorical variables, relative risk was used as the effect index for meta-analysis. Heterogeneity tests were based on P -value obtained from Q tests combined with the I 2 statistic. Among them, the I 2 statistic is an important indicator of heterogeneity, the value of 25%, 50% and 75%, representing low, medium and high heterogeneity (doi.org/10.1136/bmj.327.7414.557). If there is no significant heterogeneity between each study, i.e., I 2   .1, a meta-analysis is performed using a fixed-effect model (Mantel–Haenszel method). Instead, a random effects model (DerSimonian–Laird method) will be used. Subgroup analysis and regression analysis were based on efficacy evaluation criteria and duration of treatment to determine the magnitude and source of heterogeneity among studies. Sensitivity analysis was used to evaluate the robustness of the meta-analysis results. Funnel plots were created to assess whether publication bias existed in the included literature, and Egger or Begg methods were used for statistical testing (the number of studies should be ≥ 5). For the results with significant publication bias, the shear compensation method was used to measure the impact of publication bias on the results.

A total of 473 articles were retrieved from the initial database search, and no additional studies were identified from the reference scan. After removing duplicates, 326 articles were reviewed by title and abstract. Of these, 301 articles were excluded because they did not meet the inclusion criteria, and 25 articles were carefully reviewed for full text. A total of 22 studies were included. [ 10 , 23 – 43 ] Figure 1 shows the literature screening process. The PRISMA flowchart of the literature search and selection. The basic characteristics of the included studies are in Table 1 . Basic Characteristics of the included studies. Total effectiveness rate, ②1-hour pad test for urine leakage, ③ ICIQ-SF score, and ④ IIQ-7 score. AT = acupuncture treatment, C = control group, E = experimental group, EA = electroacupuncture, NM = not mentioned, PFMT = pelvic floor muscle training. The 22 included studies involved 1974 patients from China, ranging in age from 26.56 ± 3.72 to 66.95 ± 2.41 years old. Of these, 990 participants were in the experimental group (acupuncture combined with PFMT) and 984 were in the control group (PFMT alone), published from 2019 to 2023. The sample size of the included studies ranged from 40 to 304. The outcome indicators reported are as follows: the total effective rate (n = 13), UL on a 1-hour pad test (n = 15), ICIQ-SF score (n = 15), I-QOL score (n = 2), and IIQ-7 score (n = 2). In addition, the treatment course ranges from 4 to 24 weeks. The results of bias risk assessment for the 22 included studies are shown in Figure 2 . Among the bias generated during randomization, all the included studies were randomly assigned, which was a low risk bias. Of the bias from the established interventions, 21 studies were assessed as potentially risky because they did not implement double-blinding or did not mention it, but were assessed as low-risk bias after reasonable analytical methods provided, while the remaining 1 studies were assessed as low-risk. All studies had low risk bias in missing outcome data and measurement outcomes. It was not clear from all studies whether there was selective reporting, and this risk of bias is a possible risk. Taken together, the risk of bias in the included literature was small. Assessment of risk of bias in the included studies (RCTs). RCTs = randomized controlled trials. Thirteen studies reported the total effective rate, [ 24 , 26 , 28 , 29 , 32 – 37 , 39 , 42 , 43 ] and the fixed effect model was used for meta-analysis (I 2  = 0%, P  = .518). The results demonstrated that compared with PFMT, acupuncture combined with PFMT could better improve the total effective rate (relative risk = 1.29; 95% CI: 1.21–1.37; P  < .001; Fig. 3 ). Forest plot of total effective rate. UL on a 1-hour pad test was measured in 15 studies. [ 10 , 23 , 25 , 27 , 28 , 30 – 35 , 37 , 38 , 41 , 42 ] Heterogeneity test analysis showed that there was significant heterogeneity among the included studies (I 2  = 94.2%, P  < .001), so the random effects model was used to merge the results. The meta-analysis displayed that acupuncture combined with PFMT has more advantages in reducing UL on a 1-hour pad test than PFMT alone. (WMD = −2.58; 95% CI: −3.33 to −1.84; P  < .001; Fig. 4 ). Forest plot of UL on a 1-hour pad test. UL = urine leakage. Fifteen RCTs [ 10 , 25 – 28 , 30 – 32 , 34 – 37 , 39 , 41 , 43 ] evaluated the effect of acupuncture combined with PFMT on ICIQ-SF score in women with SUI. Meta-analysis using random effects model (I 2  = 88.9%, P  < .001) indicated that compared with the control group, the ICIQ-SF score of the experimental group decreased more, and the difference was statistically significant (WMD = −2.69; 95% CI: −3.45 to 1.92, P  < .001; Fig. 5 ). Forest plot of ICIQ-SF score. ICIQ-SF = Incontinence Questionnaire-Short Form, WMD = weighted mean differences. There were 4 RCTs in which participants were assessed with the incontinence I-QOL. Of these, 2 of them used the I-QOL questionnaire (On a 100-point scale, with higher scores indicating better quality of life), [ 28 , 40 ] and the Incontinence impact questionnaire (IIQ-7) was used for the other 2 items (the total score is 20, with lower scores indicating less impact of incontinence on quality of life). [ 36 , 38 ] The meta-analysis illustrated that compared with PFMT alone, combination therapy can better improve the quality of life of patients with SUI (WMD = 11.09; 95% CI: 8.41 to 13.77; P  < .001, WMD = −3.35; 95% CI: −4.41 to 2.56; P  < .001, respectively; Fig. 6 ). (A) Forest plot of I-QOL score; (B) Forest plot of IIQ-7 score. I-QOL = Quality of life questionnaire. Of the 22 articles included, only one study described the occurrence of adverse events, including insomnia, subcutaneous edema, and fatigue, and 2 studies showed that no adverse events occurred during the study. The rest of the literature did not mention the occurrence of adverse events. To explore the source of heterogeneity, we performed subgroup analysis of total effective rate based on efficacy evaluation criteria, and subgroup analysis of total effective rate and UL on a 1-hour pad test based on treatment duration and site. After subgroup analysis, we found that under the efficacy evaluation criteria (symptom improvement; UL in 1 hour urine pad test reduced by ≥ 50%; UL in 1 hour urine pad test <1g/ICIQ-SF score decreased), total effective rate of acupuncture combined with PFMT was markedly higher than that of PFMT alone. On the contrary, under the other efficacy evaluation criteria (ICIQ-SF score decreased by ≥ 50%), there was no significant difference in the total effective rate between the experimental group and the control group (Table 2 ). However, there was only one literature using this efficacy evaluation standard, so the results should be interpreted with caution. Subgroup analysis of total effective rate based on efficacy evaluation criteria, treatment duration and treatment site. ICIQ-SF = Incontinence Questionnaire-Short Form, RR = relative risk, UL = urine leakage. The results of subgroup analysis showed that under the treatment duration (≤4weeks; 4–12weeks; and ≥12weeks) and treatment site (hypogastrium; lumbosacral portion; and hypogastrium combined with lumbosacral portion), total effective rate of acupuncture combined with PFMT was obviously higher than that of PFMT (Table 2 ). Regression analysis demonstrated that treatment duration and treatment site were not the sources of heterogeneity ( P  = .929; P  = .974, respectively). In addition, we performed a subgroup analysis of UL on a 1-hour pad test based on treatment time, and the results illustrated that under different treatment duration (≤4 weeks; 4–12 weeks; and ≥12 weeks), patients in the combination group had lower UL on a 1-hour pad test than that in the PFMT group ( P  = .001, P  < .001, P  < 0.001, respectively; Table 3 ). Regression analysis further showed that the duration of treatment was not the source of heterogeneity ( P  = .099). Subgroup analysis of UL on a 1-hour pad test based on treatment duration and site. Moreover, subgroup analysis of the UL on a 1-hour pad test according to treatment site showed that different treatment site (hypogastrium; lumbosacral portion; hypogastrium combined with lumbosacral portion) did not affect the result of the experimental group being superior to the control group ( P  = .012, P  < .001, P  < .001; Table 3 ). Regression analysis further displayed that treatment site was not the source of heterogeneity ( P  = .568). We performed a sensitivity analysis for the total effective rate and UL on a 1-hour pad test, and assessed the impact of each study on the pooled results through a one-by-one exclusion method. The analysis showed that none of the combined results were significantly affected by any single study. This suggests that the results of this meta-analysis are generally relatively reliable. Sensitivity analysis was shown in following Figure 7 . (A) Sensitivity analysis of total effective rate. (B) Sensitivity analysis of UL on a 1-hour pad test. UL = urine leakage. To ensure the validity of the meta-analysis results, we used funnel plots, Egger and Begg tests to identify publication bias in total effective rate and UL on a 1-hour pad test. The results manifested that UL on a 1-hour pad test had no significant publication bias ( P  > .05), but there was significant publication bias in the total effective rate ( P  = .012). After supplementing 2 literatures with trim and fill method, the conclusions did not change, which further confirmed the reliability of our results.

Our study found that acupuncture combined with PFMT could significantly increase the total effective rate of female patients with SUI, decrease the UL on a 1-hour pad test, and improve the ICIQ-SF score and the quality of life of SUI’s patients. The maintenance of urethral sphincter closure and the support of intact pelvic floor muscles are fundamental to the control of urine. [ 44 – 46 ] Braekken et al [ 47 ] reported that women undergoing PFMT showed increased pubic visceral muscle thickness, shrinked levator ani hiatus area, and shortened pubic visceral muscle length in the resting state, indicating that PFMT can increase pelvic floor muscle strength, volume, endurance, and motor coordination. Acupuncture has a long history in the treatment of SUI. [ 48 ] Tang et al [ 10 ] evaluated 1-hour pad tests in which UL was reduced by 9.8 g (70.5%) in the PFMT + electroacupuncture (EA) group and by 5.8 g (42.6%) in the PFMT + sham EA group, demonstrating the significant advantage of combination therapy, and the effect of combination therapy was maintained at 30-week follow-up. Engberg et al [ 49 ] found that women treated with acupuncture had an average reduction of 63.3% in daytime UI episodes compared with 18.88% in women treated with sham acupuncture for 6 weeks. A systematic review of 31 RCTs suggested that the combination of moxibustion, PFMT, electromyographic biofeedback was the most effective in reducing ICIQ-SF compared with the single treatment (moxibustion/acupuncture/PFMT/ electromyographic biofeedback) [ 50 ] which presents the importance of combination therapy, and was similar to the results of the our study. An in vitro study showed that EA of Shenshu (BL23) and Huiyang (BL35) could enhance the leak point pressure and maximum bladder capacity in SUI rats, and also significantly increased the protein expression of collagen I and collagen III in the anterior vaginal wall of SUI rats. Morever, the protein expressions of MMP1, MMP2, and MMP9 were obviously decreased. These results suggest that the mechanism of EA in treating SUI may be related to promoting the degradation of collagen in the anterior vaginal wall, which provides a theoretical basis for the treatment of SUI with acupuncture combined with PFMT. [ 51 ] Another study found that c-Fos expression was increased in the pontine micturition center, ventrolateral periaqueductal gray, and medial preoptic nucleus in SUI model rats, and acupuncture with Sanyinjiao (SP6) significantly reduced c-Fos expression in these areas. This finding suggests that the therapeutic effect of acupuncture on SUI may be connected with the regulation of c-Fos expression in the brain. [ 52 ] Subgroup analysis was performed according to efficacy evaluation criteria, treatment duration and treatment site. The results demonstrated that different efficacy evaluation criteria did not change the total effective rate of the combination therapy. In addition, treatment duration (≤4 weeks, 4–8 weeks, or ≥ 12 weeks) and treatment site (hypogastrium, lumbosacral portion, or hypogastrium combined with lumbosacral portion) did not affect the effectiveness of combination therapy on the total effective rate and UL on 1-hour pad test. Therefore, in the treatment of SUI, we should pay attention to shorten the treatment duration, lower the treatment cost, simplify the acupoint selection, and rationally allocate medical resources. However, due to the limited number and the low quality of the included studies (different efficacy evaluation criteria, different treatment regimens, different acupoints, and acupuncture methods), the results should be interpreted with caution. The limitations of this study include: Initially, most of the studies included in this meta-analysis were single-center studies and were conducted in China, which may bring resistance to the international promotion of combination therapy. Secondly, the high heterogeneity, which may be related to the acupuncture method (EA, MA, FSN, WA, etc), the frequency of acupuncture (3 times a week, 5 times a week, etc), and the age, gender and race of the study population. Thirdly, of the 22 RCTs included in this article, only one study reported the occurrence of adverse events. Based on the available data on adverse reactions, we observed a relatively low probability of adverse reactions during acupuncture treatment and no significant severe cases were reported. In other words, acupuncture treatment may have a high safety. However, relying on these limited data alone may not fully assess the real-world risks associated with acupuncture. Last but not least, the particularity of acupuncture therapy brings challenges to the implementation of the double-blind method.